Artificial organ or part or section thereof for implanation into the human body and method of producing the same

ABSTRACT

An artificial organ or part thereof for implantation into the human body is synthesized from a mixture of albumen and human blood of a selected blood group corresponding to the blood group of the acceptor body, the mixture being plastified and molded into a desired shape, and after hardening and drying constitutes a ready-to-use artificial organ or part thereof.

United States Patent [191 Fiihr et a1.

[45] Nov. 11, 1975 ARTIFICIAL ORGAN OR PART OR SECTION THEREOF FOR IMPLANATION INTO THE HUMAN BODY AND METHOD OF PRODUCING THE SAME Inventors: Jiirgen Fiihr, l-lolitzberg 83, Hamburg; Helmut Fettback, Eichenweg 8, Buxtehude, both of Germany Filed: May 29, 1974 Appl. No.: 474,154

Foreign Application Priority Data May 29, 1973 Austria .1 4679/73 US. Cl 3/1; 3/1.4; 128/334 R;

106/124; 264/340 Int. Cl. A61F l/24 Field of Search 3/1, DIG. l, 1.4;

[56] References Cited UNITED STATES PATENTS 2,457,804 l/l949 Bower 128/3355 3,272,204 9/1966 Artandi et a1 3/D1G. 1 3,523,807 8/1970 Gerendas 1. 3/1 X Primary E.\-aminerRonald L. Frinks Attorney, Agent, or FirmToren, McGeady and Stanger ABSTRACT 6 Claims, N0 Drawings ARTIFICIAL ORGAN OR PART OR SECTION THEREOF FOR IMPLANATION INTO THE HUMAN BODY AND METHOD OF PRODUCING THE SAME BACKGROUND OF THE INVENTION The present invention relates to artificial organs, parts or sections and the like of artificial organs that are adapted to be implanted into the human body, and a mehtod of producing such artificial organs or the like, in providing an immunizing protection whereby such organs are synthetized from a mixture of albumen and blood.

It is already known to transplant human, animal, vegetable or artificial parts of a body to another location of the same animate being or onto a different animate being. The major difficulty in the implantation of artificial body parts or members arises in the field of the biological immunity reaction of the human body against the alien organ or against parts or sections or organs that are foreign to the human body. The plasm cells and the lymphocytes especially contribute to a substantial degree to the formation of antibodies against foreign matter and foreign substances. These cells are likewise responsible for the incompatibility reaction of the human body resulting from a transplantation or from the implantation of organs into unfamiliar organisms. In the transplantation of organs, therefore, the metabolism of the plasm cells and of the lymphocytes must be interfered with in a manner preventing the plasm cells and the lymphocytes from initiating the production of antibodies against the alien organ. This may be achieved either by administering medications or by eg covering with living cells the organs intended to be implanted. Both these expedients, however, are rather cumbersome and do not always lead to the desired success since the generation of antibodies may also be initiated after a relatively long time has lapsed since the transplantation of the organ has been performed. The technique of covering the organs to be transplanted with living cells is accompanied by problems of the stability of the cells at the artificial organs.

In a heretofore known highly porous artificial adhesive bonding type tissue blood vessel and a method of producing the same the artificial organ comprises a tube made of a non-resorbing physiologically inert synthetic fiber tissue forming an outer layer of the artificial blood vessel, and a self-supporting tube made of an adhesive bonding material the reabsorption properties of which are modified by a partial chemical hardening operation and forming an inner layer whereby the inner surface of the adhesive bonding tube is treated with an anticoagulation agent. The support member of this prothesis therefore consists of a synthetic fiber tissue.

Furthermore, there is already known a tissue pad for implantation into a living organism and a method and an apparatus for producing the same. This tissue pad is characterized by a support or reinforcing member made of a coating of living tissue which is arranged adjacent to an inner surface of the reinforcing member and extends inwardly from this surface whereby the shape of the tissue pad corresponds to the configuration of a mold cavity in which the tissue pad has been cultivated. This prior art tissue pad, therefore, does not consist of a mixture of albumen and blood.

There is also known an artificial vessel implantation technique for chirurgical uses wherein the tissue includes an organic component that may be reabsorbed by the human body, and exhibits prior to implantation a very tight screen structure rendering the tissue virtually impermeable to blood, and the initial porosity of this screen structure is within a range from 0 to 500 and preferably has a value of 50 according to the scale of Wesolowski. The multi-component tissue includes, at least partly, evenly spaced compound yarns containing filaments of a non-absorbing synthetic substance having suitable strength, flexibility and elasticity. These fil aments are compatible with living tissue, will not alter in any substantial degree, may be wetted by blood, and may be sterilized. The composite yarns, furthermore, include biologically absorbable filament strands of an animal material having a haemostatic effect sufficient to prevent bleeding-through in the early stages of the implantation whereby the synthetic filaments serve as a strong supporting skeleton for the porous flexible tubular structure. Moreover, the proportion of filaments in the tissue that are made of animal material is selected in a manner so that upon biological absorption of the same the porosity of the tissue attains an ultimate value of at least 5,000, and is preferably in a range from 10,000 to 20,000 or in excess thereof, according to the scale of Wesolowski. This artificially implanted vessel likewise is not synthetized from albumen and blood.

Likewise known are prothesis-type tubular organs and methods of manufacturing the same. A textile web reinforced prothesis of this type for tubular organs consists of a nonporous interiorly smooth hydrogel layer into which is polymerized a textile lining.

Apart from protheses of this type there have also been proposed artificial veins and vessels such as aortas and tracheas. For manufacturing vessel portions of this type, there is likewise not employed a mixture of albumen and blood.

DETAILED DESCRIPTION OF THE INVENTION It is therefore an object of the present invention to provide a novel and improved artificial organ, a part or a section or the like of an artificial organ which do not provoke the generation of antibodies in the human body and which will not be rejected by the human body.

Surprisingly, it has been found that an artificial organ provides a strong immunizing protection if the artificial organ consists of a molded body or is covered with a coating either of which is produced, in accordance with the present invention, by preparing a mixture of artificial albumen or a protein and human blood of a blood group correspondingto the blood group of a person into the body of whom an artificial organ is to be implanted, plastifying the mixture, then molding the mixture into the shape of the desired artificial organs, subsequently hardening the molded organs and upon termination of the hardening step, drying the organs.

It is another object of the present invention to provide an artificial organ made by the above described method wherein the artificial organ itself or, if the artificial organ is made from any suitable material, a coating covering the artificial organ respectively consists of a plastomer hardened by means of a hardener such as a formaldehyde solution, and the plastomer is made from 10 to percent artificial albumen or protein and from 80 to 10 percent of human blood of a blood group corresponding to the blood group of the human body of a patient.

The basic components employed for producing artificial organs of this type according to the present invention may consist of albumcns or albumen-containing substances such as lactic albumen, mother's milk and the like as well as proteins. The blood for producing these artificial organs is human blood of a blood group corresponding to the blood group of the person into whose body the artificial organ is intended to be inserted.

The percentage proportions of the basic components for producing the artificial organs range from l to 80 percent albumen and correspondingly from 80 to l0 percent blood. The hardener may consist of a formaldehyde solution of between 2 to percent.

The method of the present invention allows to readily produce the most varied types of organs, parts and sections of organs suitable for implantation into the human body. These organs may consist exclusively of the plastomer made of human blood of a blood group corresponding to the blood group of a person into whose body the artificial organ is intended to be implanted, and albumen.

According to an alternate embodiment of the present invention, artificial organs made from any suitable material may be covered with a coating consisting of a plastomer made of human blood of a blood group corresonding to the blood group of a person into whose body the artificial organ is intended to be implanted, and albumen.

In the following, the method of the present invention will be illustrated by means of an example that is not intended to delimit the scope of the invention as defined in the appended claims:

20 percent of albumen and 80 percent of blood of one or several human donors whose blood group corresponds to the blood group of the person intended to re ceive the artificial organ are mixed. and then the resulting mixture is plastified by pressing and kneading in an extruder press. The homogeneous mass obtained in the preceding step is then molded into the shape of the desired artificial organ or is applied as a coating onto a molded body, and subsequently hardened. The hardener may consist of a aqueous formaldehyde solution in a concentration of between 2 to 20 percent, or a catalyst suitable for hardening albumen or blood respectively. The hardening period of the molded body depends upon the thickness of the molded body and may extend over several weeks or months. Following this hardening step, the molded body is dried. The molded bodiesmay subsequently be machined or cut.

It would likewise be feasible to use parts or molded bodies made of albumen and blood as supporting struetures for organic cells or tissue layers.

Every organ intended for implantation into the human body may be produced according to the method of the present invention. Monitoring devices and the like which are implanted into the human body may likewise be covered with a coating produced in accor- 4 dance with the present invention so that the implanted organ or device is provided with a strong immunizing protection.

Prothcses or parts of protheses produced according to the method of the present invention will be pre-fabricatcd and put at the disposal of the chirurgist or surgeon for implantation into the human body. The artificial organs produced in accordance with the method of the present invention will thus be ready for use by a surgeon in a manner analogous to blood in blood plasm banks containing blood of the various blood groups. The artificial organs will be produced and stored in adaptation to the various blood groups.

What is claimed is:

1. In a method of producing artificial organs and parts, sections and the like of artificial organs, adapted to be implanted into a human body, comprising plasticizing a mixture for making the artificial organ into a mass, forming the mass into the shape of the desired artificial organ, and hardening and drying the product resulting from the forming wherein the improvement comprises preparing a mixture of one of artificial albumen, and protein, and human blood of a blood group corresponding to the blood group of a person into the body of whom an artificial organ is to be implanted so.

as to provide such organ with an immunizing protection.

2. The improvement according to claim 1, wherein said step of plasticizing a mixture comprises employing from 10 to percent of one of albumen and protein and from 80 to 10 percent of the human blood of a blood group corresponding to the blood group of a person into the body of whom the artificial organ is to be implanted.

3. A method as defined in claim ll, wherein the hardener employed is an aqueous formaldehyde solution having a concentration of from 2 to 20 percent.

4i. The improvement according to claim 1, wherein said step of forming the mass into the shape of the desired artificial organ comprises coating the artificial organ made of suitable material with the mixture after the step of plasticizing.

5. An artificial organ and parts, sections and the like of artificial organs, adapted to be implanted into a human body comprising a hardened plastomer, said plastorner comprising H) to 80 percent of one of artificial albumen and protein and 80 to 10 percent human blood of a blood group corresponding to the blood group of the patient in which the artificial organ is to be implanted.

6. The artificial organ according to claim 5, further comprising an inner portion made of suitable material,

said plastomer coating and surrounding said inner portion to form said artificial organ. 

1. In a method of producing artificial organs and parts, sections and the like of artificial organs, adapted to be implanted into a human body, comprising plasticizing a mixture for making the artificial organ into a mass, forming the mass into the shape of the desired artificial organ, and hardening and drying the product resulting from the forming wherein the improvement comprises preparing a mixture of one of artificial albumen, and protein, and human blood of a blood group corresponding to the blood group of a person into the body of whom an artificial organ is to be implanted so as to provide such organ with an immunizing protection.
 2. The improvement according to claim 1, wherein said step of plasticizing a mixture comprises employing from 10 to 80 percent of one of albumen and protein and from 80 to 10 percent of the human blood of a blood group corresponding to the blood group of a person into the body of whom the artificial organ is to be implanted.
 3. A method as defined in claim 1, wherein the hardener employed is an aqueous formaldehyde solution having a concentration of from 2 to 20 percent.
 4. The improvement according to claim 1, wherein said step of forming the mass into the shape of the desired artificial organ comprises coating the artificial organ made of suitable material with the mixture after the step of plasticizing.
 5. An artificial organ and parts, sections and the like of artificial organs, adapted to be implanted into a human body comprising a hardened plastomer, said plastomer comprising 10 to 80 percent of one of artificial albumen and protein and 80 to 10 percent human blood of a blood group corresponding to the blood group of the patient in which the artificial organ is to be implanted.
 6. The artificial organ according to claim 5, further comprising an inner portion made of suitable material, said plastomer coating and surrounding said inner portion to form said artificial organ. 